Acute Ischemic StrokeNITE1NCT04881162
Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System
A study testing NOVIS Transcarotid Neuroprotection System (NPS) in people with Acute Ischemic Stroke, run by Silk Road Medical at 1 site in United States.
Trial summary
Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- NOVIS Transcarotid Neuroprotection System (NPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices)
- 2. Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments
- 3. Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture
Who cannot join
- 1. Significant disease of the ipsilateral common carotid artery on routine CTA
- 2. Presence of a cervical ICA loop or other high-risk anatomical features of the ICA on routine CTA, that may preclude the use of the NOVIS NPS
- 3. Any active or recent hemorrhage within the past 30 days
- 4. Embolectomy contraindications
- Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5
- 5. IV tPA has been or is being administered
- 6. Last known well > 24 hours ago
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy
Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.
Read the detailed description
This is a prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. Patients enrolled into the NITE 1 Study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.
- Conditions
- Acute Ischemic Stroke
- Being tested
- NOVIS Transcarotid Neuroprotection System (NPS)
- Keywords
- mechanical thrombectomy, stroke treatment, embolic protection, transcarotid
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVIS Transcarotid Neuroprotection System (NPS)Device
The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection
| Study group | Role | What they receive |
|---|---|---|
| NOVIS Transcarotid Neuroprotection System (NPS) | Experimental | Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS. Receives: Device: NOVIS Transcarotid Neuroprotection System (NPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Device-related Serious Adverse Events
The primary outcome measure assesses the number of vascular complications which include which include dissection, pseudoaneurysm, hematoma, arteriovenous fistula, thrombus formation, embolization and any vascular complication that may be attributed to the device AND requires surgical repair, surgical wound revision, transfusion, etc. The endpoint is measured at 90 days post-procedure.
Measured: 90 Days
Number of Other Serious Adverse Events
The primary outcome measure assesses the number of permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices. The endpoint is measured at 90 days post-procedure.
Measured: 90 Days
Number of Subjects With Functional Independence
Functional independence will be evaluated by assessing the modified Rankin scale (mRS). The mRS comprises six levels from 0 to 5 of increasing severe disability with an additional level 6 indicating death. A lower score indicates a better outcome and a higher score indicates a worse outcome. A mRS score reported between 0 to 2 will be considered functionally independent and 3 to 6 to not be functionally independent or dead at point of measurement. The endpoint is measured at 90 days post-procedure.
Measured: 90 Days
Secondary outcomes (6)
Carotid Access Time
The endpoint measures the hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization which includes the securement of the sheath, neck incision to femoral venous sheath access which includes the securement of the sheath, and neck incision to initiation of reverse flow.
Measured: Hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization, neck incision to femoral venous sheath access which, and neck incision to initiation of reverse flow.
Time to Final Revascularization
The endpoint measures the time of hospital arrival to operating room (OR), last known well to final revascularization, admission to final revascularization, OR to final revascularization, Cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow time including common carotid artery (CCA) clamp to CCA unclamp.
Measured: Hospital arrival to OR, LKW to final revascularization, admission to final revascularization, OR to final revascularization, cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow.
Number of Device-Related Complications
This outcome measure assesses the number of reported complications that may be attributed to the device through the end of all patient follow up in the study.
Measured: 90 Days
Neurologic Assessment
The outcome measure measures neurological worsening of patients according to the National Institutes of Health Stroke Scale (NIHSS) at 90 days post procedure. The NIHSS is a graded neurological examination that assesses consciousness, eye movements, visual fields, motor and sensory impairments, ataxia, speech, cognition and inattention. The NIHSS is a combination of 11 components each with a particular scale as follows: level of consciousness (1a: 0-3, 1b: 0-2 and 1c: 0-2), best gaze (0-2), visual fields (0-3), facial palsy (0-3), arm motor (0-4), leg motor (0-4), limb ataxia (0-2), sensory (0-2), best language (0-3), dysarthria (0-2), extinction and inattention (0-2). The components are summed, and a lower score indicates better outcomes, and higher score indicates worse outcomes. A neurological worsening similar to a non-disabling stroke is considered scored less than or equal to 4 and a neurological worsening similar to a disabling stroke with a score equal to or greater than 5.
Measured: 90 Days
Technical Sucess Rate
The outcome measure will count the number patients with successful introduction of endovascular tools through the NOVIS Transcarotid NPS during the procedure. Introduction of endovascular tools will be considered successful if NPS was placed, reverse flow was established, and interventional tools were successfully delivered.
Measured: Start to end of index procedure
Revascularization Sucess Rate
The outcome measure reports the number of patients with modified thrombolysis in cerebral infarction (mTICI) score evaluated by the contract core lab measuring angiograms collected from baseline to immediately after the end of the index procedure. The mTICI grading scale is a tool for determining the response of thrombolytic therapy for ischemic stroke on a scale between 0 to 3. A lower score indicates better outcomes and higher score indicates worse outcomes The score 2 has two additional grades of severity of 2a and 2b indicating worse outcomes along the alphabetical progression of the scale.
Measured: Start to end of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start2 Nov 2021
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Why it stopped: Sponsor decided to terminate study early solely due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with acute ischemic anterior circulation stroke due to large vessel embolic occlusion who are candidates for endovascular therapy and in whom transfemoral therapy failed.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Road Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Matouk, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881162
- Sponsor's protocol ID
- SRM-2019-01
- Acronym
- NITE1
- Status last verified
- Jan 2025
- First submitted
- 30 Apr 2021
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy
- ClinicalTrials.gov ID
- NCT04881162
- Acronym / sponsor ID
- NITE1 / SRM-2019-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- mechanical thrombectomy, stroke treatment, embolic protection, transcarotid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to terminate study early solely due to slow enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Silk Road MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.
Detailed description
This is a prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. Patients enrolled into the NITE 1 Study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with acute ischemic anterior circulation stroke due to large vessel embolic occlusion who are candidates for endovascular therapy and in whom transfemoral therapy failed.
| Arm | Type | Receives |
|---|---|---|
| NOVIS Transcarotid Neuroprotection System (NPS) | Experimental | Device: NOVIS Transcarotid Neuroprotection System (NPS)Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices)
- 2. Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments
- 3. Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture
Key exclusion criteria (7 listed)
- 1. Significant disease of the ipsilateral common carotid artery on routine CTA
- 2. Presence of a cervical ICA loop or other high-risk anatomical features of the ICA on routine CTA, that may preclude the use of the NOVIS NPS
- 3. Any active or recent hemorrhage within the past 30 days
- 4. Embolectomy contraindications
- 5. IV tPA has been or is being administered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVIS Transcarotid Neuroprotection System (NPS)The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection | Device | NOVIS Transcarotid Neuroprotection System (NPS) |
Primary outcome
Number of Device-related Serious Adverse Events
Time frame: 90 Days
The primary outcome measure assesses the number of vascular complications which include which include dissection, pseudoaneurysm, hematoma, arteriovenous fistula, thrombus formation, embolization and any vascular complication that may be attributed to the device AND requires surgical repair, surgical wound revision, transfusion, etc. The endpoint is measured at 90 days post-procedure.
Number of Other Serious Adverse Events
Time frame: 90 Days
The primary outcome measure assesses the number of permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices. The endpoint is measured at 90 days post-procedure.
Number of Subjects With Functional Independence
Time frame: 90 Days
Functional independence will be evaluated by assessing the modified Rankin scale (mRS). The mRS comprises six levels from 0 to 5 of increasing severe disability with an additional level 6 indicating death. A lower score indicates a better outcome and a higher score indicates a worse outcome. A mRS score reported between 0 to 2 will be considered functionally independent and 3 to 6 to not be functionally independent or dead at point of measurement. The endpoint is measured at 90 days post-procedure.
6 secondary outcomes
Carotid Access Time
Time frame: Hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization, neck incision to femoral venous sheath access which, and neck incision to initiation of reverse flow.
Time to Final Revascularization
Time frame: Hospital arrival to OR, LKW to final revascularization, admission to final revascularization, OR to final revascularization, cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow.
Number of Device-Related Complications
Time frame: 90 Days
Neurologic Assessment
Time frame: 90 Days
Technical Sucess Rate
Time frame: Start to end of index procedure
Revascularization Sucess Rate
Time frame: Start to end of index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Matouk, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVIS Transcarotid Neuroprotection System (NPS) in people with Acute Ischemic Stroke, run by Silk Road Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Device-related Serious Adverse Events (time frame: 90 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.